FDA Enforcement
Class I
Ongoing
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Recall: Z-0905-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0905-2025
- Event ID
- 95898
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- December 18, 2024
- Classification Date
- January 16, 2025
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Reason
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Code Info
Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Distribution
US Nationwide Distribution
Quantity
30,140 units